Real-World Clinical Experience of Patients With Metastatic Castration-Resistant Prostate Cancer Treated With Olaparib + Abiraterone (PROceed)

A Prospective Observational Study to Evaluate Real-world Clinical Outcomes and Characteristics of Patients With mCRPC Treated With Olaparib + Abiraterone

Status

Active, not recruiting

Phases

Unknown

Study type

Observational

Source

ClinicalTrials.gov

Registry ID

NCT06380738

Acronym

PROceed

Enrollment

111

Registered

2024-04-24

Start date

2024-02-14

Completion date

2027-02-14

Last updated

2026-09-16

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Metastatic Castration-resistant Prostate Cancer

Brief summary

PROceed is a multisite, prospective, observational study that describes the real-world use and clinical experience of mCRPC patients treated with the combination of olaparib and abiraterone in the mCRPC setting. Clinical outcomes will be assessed in patients who are either NHA-naive or NHA-exposed prior to initiating olaparib + abiraterone treatment, respectively. Patient demographic and clinical characteristics, as well as treatment received prior and subsequent to olaparib + abiraterone, will also be described. The study plans to enroll patients for a maximum of 2 years and follow up patients from initiation of olaparib until 1 year post last patient in.

Interventions

None listed

Study design

Observational model

COHORT

Time perspective

PROSPECTIVE

Eligibility

Sex/Gender

MALE

Age

18 Years to No maximum

Healthy volunteers

Inclusion criteria

* Willing and able to provide written informed consent; * 18 years of age and above; * Documented histopathology or cytopathology of PCa, adenocarcinoma; * Confirmed as mCRPC; * Initiated olaparib + abiraterone after site activation

Exclusion criteria

* Patients participating in a clinical trial with an investigational prostate cancer treatment within 30 days prior to olaparib initiation

Design outcomes

Primary

Measure	Time frame	Description
Time to treatment discontinuation	Up to 12 months	Time to treatment discontinuation (TTD) event-free rate at 6 months and 12 months will be assessed among patients treated with olaparib + abiraterone in 1L mCRPC setting by prior NHA exposure status (NHA-exposed and NHA-naive), respectively. TTD is defined as the time from initiation of olaparib therapy until end date of olaparib therapy or death due to any cause.

Secondary

Measure	Time frame	Description
Time to first subsequent therapy	Up to 24 months	Time to first subsequent therapy (TFST) in mCRPC patients treated with olaparib + abiraterone. TFST is defined as the time from olaparib initiation to the earlier of the first subsequent anticancer therapy start date following olaparib discontinuation or death due to any cause.

Countries

Germany

Outcome results